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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03915496




Registration number
NCT03915496
Ethics application status
Date submitted
22/03/2019
Date registered
16/04/2019
Date last updated
8/02/2023

Titles & IDs
Public title
Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
Scientific title
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE MECHANISM OF ACTION OF ABROCITINIB MONOTHERAPY IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
Secondary ID [1] 0 0
JADE MOA
Secondary ID [2] 0 0
B7451037
Universal Trial Number (UTN)
Trial acronym
JADE MOA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-04965842 200 mg
Treatment: Drugs - PF-04965842 100 mg
Treatment: Drugs - Placebo

Experimental: PF-04965842 200 mg -

Experimental: PF-04965842 100 mg -

Placebo Comparator: Placebo -


Treatment: Drugs: PF-04965842 200 mg
PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks

Treatment: Drugs: PF-04965842 100 mg
PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks

Treatment: Drugs: Placebo
Placebo administered as two tablets to be taken orally once daily for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline at Week 2, 4, 8 and 12
Timepoint [6] 0 0
Baseline, Weeks 2, 4, 8, and 12
Secondary outcome [7] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response = 75% Improvement From Baseline Week 2, 4, 8 and 12
Timepoint [7] 0 0
Baseline, Week 2, 4, 8, and 12
Secondary outcome [8] 0 0
Percentage of Participants With >=4 Points at Baseline and Achieving >=4 Points Improvement From Baseline in Numeric Rating Scale for Severity of Pruritus (PP-NRS) at Weeks 2, 4, 8 and 12
Timepoint [8] 0 0
Baseline, Week 2, 4, 8, 12
Secondary outcome [9] 0 0
Percentage of Participants Achieving EASI Response = 90% Improvement From Baseline at Week 2, 4, 8 and 12
Timepoint [9] 0 0
Baseline to Week 2, 4, 8 and 12
Secondary outcome [10] 0 0
Percentage of Participants Achieving EASI Response = 50% Improvement From Baseline at Week 2, 4, 8 and 12
Timepoint [10] 0 0
Baseline to Week 2, 4, 8 and 12
Secondary outcome [11] 0 0
Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12
Timepoint [11] 0 0
Baseline and Week 2, 4, 8 and 12
Secondary outcome [12] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [12] 0 0
Baseline to 16 weeks
Secondary outcome [13] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [13] 0 0
Baseline to 16 weeks
Secondary outcome [14] 0 0
Number of Participants Who Discontinued From the Study Due to TEAEs
Timepoint [14] 0 0
Baseline to 16 weeks
Secondary outcome [15] 0 0
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Timepoint [15] 0 0
Baseline to 16 weeks

Eligibility
Key inclusion criteria
- Clinical diagnosis of chronic moderate-to-severe atopic dermatitis (AD) for at least 1
year

- Recent history of inadequate response to medicated topical therapy for AD or required
systemic therapy to control disease

- Moderate-to-severe AD defined as affected BSA at least 10%, IGA at least 3, EASI at
least 16, Peak Pruritus NRS at least 4
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A current or past medical history of conditions associated with thrombocytopenia,
coagulopathy, or platelet dysfunction

- Currently have active forms of other inflammatory skin diseases, i.e. not AD, or have
evidence of skin conditions (e.g. psoriasis, seborrheic dermatitis, lupus) at the time
of Day 1 that would interfere with evaluation of AD or response to treatment

- Participants who have received prior treatment with any systemic JAK inhibitors

- Require treatment with prohibited concomitant medication(s) or have received a
prohibited concomitant medication within specified time frames prior to the first dose
of study medication, including topical treatments that could affect AD

- Pregnant or breastfeeding women or sexually-active women of childbearing potential who
are unwilling to use contraception

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2021
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to
investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with
changes from baseline in key skin and blood biomarkers in adult participants at least 18
years of age with moderate-to-severe atopic dermatitis. Participants will be screened within
28 days prior to the first dose of study intervention to confirm eligibility. A total of
approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200
mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of
the 12-week study treatment, qualified participants will have the option to enter the
long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this
study will undergo a 4-week off-treatment follow-up period.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03915496
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries